Expired Study
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Duluth, Minnesota 55805


Purpose:

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known whether radiation therapy is more effective than observation only after sugery in treating endometrial cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to observation only in treating patients with stage I or stage II endometrial cancer who have undergone hysterectomy and oophorectomy.


Study summary:

OBJECTIVES: - Compare the overall survival in patients with intermediate-risk endometrial cancer treated with pelvic radiotherapy vs observation after laparoscopically-assisted vaginal hysterectomy or total abdominal hysterectomy and bilateral salpingo-oophorectomy. - Compare the time to locoregional recurrence (i.e., in the vaginal mucosa or elsewhere in the central pelvic area or lateral pelvic walls) in patients treated with these regimens. - Compare the duration of ultimate pelvic control and event-free survival in patients treated with these regimens. - Compare the toxic effects of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. - Compare sexual health issues in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, tumor grade (1 vs 2 vs 3), surgical staging (yes vs no), and sexual health assessment (yes vs no). Patients undergo laparoscopic-assisted vaginal hysterectomy or total abdominal hysterectomy and bilateral salpingo-oophorectomy. After surgery, patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo observation alone. - Arm II: Beginning within 12 weeks (preferably within 6-8 weeks) after surgery, patients undergo radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Protocol-defined brachytherapy is allowed. Quality of life is assessed at baseline; at 16-18 weeks after surgery (arm I) or 5 and 9 weeks after initiating radiotherapy (arm II); and then at 6, 12, 18, 24, 36, 48, and 60 months. Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven adenocarcinoma or adenosquamous cell carcinoma of the endometrium - Intermediate-risk of recurrence after laparoscopically-assisted vaginal hysterectomy (with or without laparoscopic staging) or total abdominal hysterectomy and bilateral salpingo-oophorectomy - Postoperative pathologic stage IA/IB (grade 3), stage IC (grade 1-3), or stage IIA (all grades) - Patients with more than 50% myometrial invasion (grade 1 or 2) or less than 50% myometrial invasion (grade 3) but with positive peritoneal cytology also eligible - Patients whose sole criterion for increased risk is positive peritoneal cytology are not eligible - No pathologically involved lymph nodes if staging procedure performed - Stage I papillary serous or clear cell endometrial cancer allowed PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - ECOG 0-3 Life expectancy: - At least 3 years Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Not specified Renal: - Creatinine less than 2 times upper limit of normal - No serious renal disease that would preclude radiotherapy Cardiovascular: - No serious cardiovascular disease that would preclude radiotherapy Other: - No history of inflammatory bowel disease such as ulcerative colitis - No other malignancy within past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, colon cancer, or thyroid cancer - No psychiatric or addictive disorder that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No prior anticancer hormonal therapy - No concurrent progestogens Radiotherapy: - No prior pelvic irradiation - No prior or other concurrent vaginal intracavitary radiotherapy Surgery: - See Disease Characteristics Other: - No prior anticancer therapy - No other concurrent anticancer therapy


NCT ID:

NCT00002807


Primary Contact:

Study Chair
Himu R. Lukka, MD
Margaret and Charles Juravinski Cancer Centre


Backup Contact:

N/A


Location Contact:

Duluth, Minnesota 55805
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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